All posts by BIadmin

FDA: Breast Implant Safety Studies Will Continue

After two days of testimony on what the FDA should do about troubled long-term safety studies of silicone-gel breast implants, agency officials said the studies would continue.

“The current post-approval studies will continue,” said William Maisel, MD, MPH, chief scientist in the FDA’s Center for Devices and Radiological Health, in remarks after the meeting. “The FDA is committed to seeing them completed and making sure the follow-up rates improve.”

The safety studies in question, of nearly 100,000 women with breast implants, which the FDA said were the largest ever required of manufacturers after their devices were marketed to the public, have lost track of up to 79% of the women they enrolled just three years into planned 10-year efforts.

As a result, FDA epidemiologists testified yesterday, the studies had lost the ability to find rare complications, including connective tissue diseases, that they were designed to look for. […]

Consumer advocates, like Dana Casciotti, PhD, the public health research director at the Cancer Prevention and Treatment Fund, said annual, 27-page questionnaires women were asked to complete should be shortened and simplified.

“I’ve seen copies of these questionnaires, and they are much too long” and technical, she said.

Read the original article here.

Breast Implant Illness: Two Metro Women Say Implants Caused Years of Complications

Ben Oldach, WHO TV: May 21, 2018

Breast implants are the most popular form of plastic surgery in the United States. Katie Krug’s followed a botched breast reduction.

“There were quite a few people that asked me when I was in a bathing suit if I had open heart surgery, so it was something that I was really self-conscious about,” said Krug.

Krug’s friend Lisa Miller received hers while living in Arizona.

“I was just in a place where everyone had them, you kind of look outwardly and everyone had them,” said Miller.

What the women say happened next was not something they expected post-surgery.

“About a year later is when I started noticing some really small symptoms. I was tired a lot more, started having some brain fog, started being really sensitive to smells, and then it just seemed like every year it got worse,” said Krug.

“I would get really dizzy all of a sudden when I would be driving, I would get nauseous, then it moved into GI symptoms, so I started to have gastritis and had to have scopes and medicines,” said Miller.

Both women say they went to doctors who couldn’t figure out what was wrong, all while new symptoms were developing.

“I wasn’t sleeping whatsoever, I was staying up all night, I almost couldn’t work, I couldn’t remember, I was teaching Pilates at that time, I couldn’t remember what I was teaching, I really couldn’t get out of bed,” Miller explained.

After not finding any answers from doctors, Miller tried adjusting her life style.

“Cleaned the house, cleaned all the chemicals, all my beauty products, ate really well, I remember my girlfriend saying, after confiding in her, ‘you’re the sickest, healthiest person I know,'” she said.

Krug says in 2011, she asked her doctor about rumors that there may be a connection between her implants and the autoimmune disease she’d been diagnosed with.

“He pretty much just laughed in my face about the possibility of there even being a link, that they’re completely safe, they’re saline, I don’t have anything to worry about, and so I just really put that out of my mind until last year,” she said.

Meanwhile, Miller was at the end of her wits.

“I just remember like, laying on the floor one night and telling my husband, ‘I’m done! I’m done, I can’t manage life,'” she said.

Miller said her husband discovered the only thing that changed before the symptoms started showing up was her surgery, and after doing some research found a Facebook group of 35,000 women, all claiming similar symptoms. Around the same time, Krug found the page, too.

“I just felt I’m not crazy, there are other people out there like me, I see hope,” said Miller.

“I really wanted to cry when I found that page, it was so emotional for me,” said Krug.

The women in the group believe they are suffering or had suffered from something being called breast implant illness, although experts say it’s a symptomatic reaction rather than an actual disease.

“If you’re putting a foreign object in your body, it would be the same as someone saying that nobody gets a side effect from taking a medication. It’s very unrealistic,” said Josh Rose.

Rose is the patient concierge at Aqua Plastic Surgery in southern Florida. He works hand-in-hand with Dr. David Rankin, who he says performs hundreds of breast explant operations a year. However, he is quick to point out that as of now, there is very little published research linking the implants to these symptoms.

“There should be more research. There has been some research, so most of what we have to go by is very anecdotal. We’re hoping there will be more research. We’re starting our own research, another doctor is starting her own research,” said Rose.

Miller and Krug consulted with a local plastic surgeon who performs explants and had theirs removed. They say they immediately started feeling better. […]

Read the original article here.

After 17 Years with Breast Implants, Princeton Woman Leads Calls for More Education, Safety

Marie Saavedra, WFAA, April 16, 2018

A North Texas woman says her implants were making her sick. Now, she’s lending her voice to the call for more information to be shared between the FDA, doctors and patients.

Jamee Cook was 21, engaged to be married and a paramedic when she made a decision that would shape the rest of her life.

“I was really active. Healthy, Young, skinny,” she said. “I was always really really flat chested and wanted to be more proportionate.”

At age 21, Cook chose to get breast implants. At 40, it is her biggest regret.

“I mean, I made this decision and I own it,” she said. “And I do feel guilty about it because it took a lot of things away from me.”

She says that included her health. Three years after surgery she developed an auto immune disease.

“Then it went downhill, just chronic fatigue, swollen lymph nodes all the time, chronic sinus infections,” Cook said. “I couldn’t get out of bed, I was having migraines two or three times a week, and I had three young kids at home!”

She says doctors had no more answers, which left her feeling helpless. Cook turned to the internet and researched, and she came to realize her implants could be the source. She was certain when she removed them after 17 years.

“I still battle fatigue off and on, but the majority of my other symptoms went away immediately,” she said.

Cook then gained new purpose. She created the group Breast Implant Victim Advocacy, a community of thousands women who say implants made them ill. She lobbied for implant safety in Washington. All of it, driven by a simple goal.

“I think that a lot of women don’t get the information they need to make a fully informed decision,” she said.

Last year, the American Society for Aesthetic Plastic Surgery said surgeons performed 333,329 breast augmentations. We asked Dallas plastic surgeon Dr. Lawrence Weider about what warnings patients can currently expect to hear from their doctors.

“There’s a whole host of risks that we discuss,” said Dr. Weider. “We have a several page consent for that we go through with them.”

But Cook argues there’s more to be done. Right now, The FDA is researching the ties between a specific type of implant causing a rare lymphoma, and last month a woman suffering from that cancer sued an implant maker in California. […]

Read the original article here.

After 17 Years With Breast Implants, Princeton Woman Leads Calls for More Education, Safety

Marie Saavedra, WFAA-ABC: April 16, 2018


PRINCETON, Tx. — A North Texas woman says her implants were making her sick. Now, she’s lending her voice to the call for more information to be shared between the FDA, doctors and patients.

Jamee Cook was 21, engaged to be married and a paramedic when she made a decision that would shape the rest of her life.

“I was really active. Healthy, Young, skinny,” she said. “I was always really really flat chested and wanted to be more proportionate.”

At age 21, Cook chose to get breast implants. At 40, it is her biggest regret.

[…]

Read the original article here.

How to Appeal a Denial


If you disagree with your health insurer’s decision to not cover a service, you have the right to appeal this decision. Many appeals are approved. Some appeals are handled by your healthcare provider, but you can also appeal a decision yourself.

Follow these steps to file an appeal:

1. Gather all relevant information

The first step to appealing your insurer’s decision is to find out why your claim was denied. Get a copy of your denial letter and any document(s) submitted to your insurance as a part of the initial claim. This might include documents such as MRI findings, lab test results, operative reports, notes from your physician(s), letters of medical necessity, or medical bills related to the claim.

You should check your denial letter to find out when the deadline to file the appeal is. Your denial letter should explain when and how to file the appeal.

You will also want to get a copy of your insurance’s Evidence of Coverage document (sometimes called the benefit policy document). From this document you can determine what procedures your plan covers.

It can also be helpful to call the insurance company’s member services phone number. You can ask them for a detailed explanation of why the procedure was denied. If you can’t get a clear explanation that makes sense to you, you can ask to speak to a supervisor. Always ask the name of the people you speak with on the phone, write it down with the date you talk to them, and ask them to “put it in the record” that you’re working on disputing the claim.

2. File an appeal form or write an appeal letter

It is likely that your insurance company will have a standardized appeal form for you to fill out. If so, filling out their form will make the process move as quickly as possible. This form usually asks for most of the information you would include in an appeal letter.

If your insurance company does not have a standardized appeal form, you need to write an appeal letter asking your insurance company to reconsider their decision.   Even if your insurance company has a standardized appeal form, an appeal letter can sometimes add more persuasive evidence.

This is known as an internal appeal. If the internal appeal is denied, you can appeal for a review by an independent third party. This is called an external appeal. The decision made by the external board is usually final and can’t be appealed.

The appeal letter should include the following:

  • Your identification: your name, claim number, policy number, member ID number and any other information that will help identify you.
  • Reason for denial: quote the exact reason for denial that they explained in the denial letter.
  • Reason why you disagree with the denial: explain why you think the procedure should be covered. To make your case stronger, you can insert relevant language from your insurance policy document that indicates the procedure should be covered. You can also get a letter from your doctor explaining why the procedure is medically necessary and include medical document(s) that prove medical necessity.
  • What you are requesting: Ask them to reconsider the denial and approve your claim based on the information you provided in the letter.

Click here for a sample appeal letter.

3. Contact your state’s Department of Insurance

If you need help filing an appeal, you can contact your state’s Department of Insurance for help. You can also contact them if you need to file a complaint against your insurance company. Click here to find your state’s Department of Insurance website.

Please contact the Breast Implant Information project for help filing an appeal at info@breastimplantinfo.org.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

Sample Appeal Letter

Here is a sample appeal letter written for a woman with severe capsular contracture and a ruptured implant who was denied coverage for her breast implant removal surgery. For help writing your own appeal letter, contact us at info@breastimplantinfo.org. Click here to download.


Breast Implant Removal Office
555 Smiles Way
Healthytown, DC 55555

April 6, 2018

XYZ Claims Department
Attention: Appeals
167 Daisy Lane
Milwaukee, OK 12345

RE: Appeal for Denial of Claim Submitted by Jane Doe

Group/Policy number: 1425-2345-1234
Date(s) of service: February 31, 2018

Dear XYZ Claims Department:

I am writing on behalf of my patient, Jane Doe, to appeal XYZ’s decision to deny coverage for her breast implant removal surgery. I recommended the surgery because Ms. Doe has severe capsular contracture, which is causing her severe pain, restricting her movements, and interfering with mammography. In addition, her right implant is broken.

Your denial letter dated November 3, 2017, states that coverage for this procedure was denied because Ms. Doe’s “current condition does not meet the needed requirements and a bilateral breast revision is not medically necessary.” According to your letter, that determination was based on XYZ’s Coverage Criteria #567 and the details of her case. Your review concluded that because Ms. Doe has “not had breast cancer surgery or a breast injury,” you cannot approve the request for explant surgery.

We respectfully ask you to reconsider that decision. According to page 23 of my patient’s XYZ Medical Policy document (copy enclosed), Ms. Doe’s plan covers all “medically necessary” services that are not expressly excluded. Her plan does exclude cosmetic procedures; however, Ms. Doe’s implant removal is NOT a cosmetic procedure. Although Ms. Doe initially had the implants placed for cosmetic reasons, I recommended permanent removal solely to treat her present medical condition.

A review of XYZ’s Coverage Criteria #567 confirms my view that removal of her implants should be considered medically necessary. The guideline states:

Removal of breast implants for any of the following conditions may be medically necessary:
– Broken or failed implant;
– Infection;
– Implant extrusion;
– Siliconoma or granuloma;
– Interference with breast cancer;
– Breast pain; and
– Painful contraction”

Ms. Doe meets several of the above-stated criteria. I diagnosed her with Baker Grade IV capsular contracture (i.e. “painful contraction”) in her left breast, which is causing her chronic pain, restricting her movements, and interfering with mammography. Because of the pain, Ms. Doe regularly takes pain medication. Additionally, the MRI detected that Ms. Doe’s right silicone gel implant has broken (failed).

Consequently, based on the aforementioned language of the XYZ Medical Policy document and XYZ Coverage Criteria #567, XYZ should consider Ms. Doe’s implant removal a medically necessary procedure. Surgical removal of breast implants is the standard medical treatment for severe capsular contracture. The surgery is not intended to improve her appearance, rather it is intended to relieve her pain and restore her functioning. There is no other equally effective treatment available to Ms. Doe that is more conservative or less costly. Without removal, Ms. Doe will continue to experience severe pain and restricted movement, and her capsular contracture will make future screening mammograms difficult, if not impossible.

Based on this information, I request that you reconsider your denial and approve coverage for Jane Doe’s breast implant removal surgery. For your convenience, I have enclosed copies of all Ms. Doe’s relevant medical records. If you need additional information, please do not hesitate to contact me at (111) 111-1111 or doctor@iworkhere.org.

Thank you for your immediate attention to this matter.

Sincerely,

Dr. David Healthcare, Chief of Breast Implant Removal Operations
NPI# 1234567890

Enclosures:
Ms. Doe’s XYZ Medical Policy
Ms. Doe’s Office Visit Notes from 11/21/2017
MRI Report from 12/10/2017
Ms. Doe’s post-operative report from 2/31/2018


	

Sample Letter of Medical Necessity

Here is a sample letter of medical necessity written for a woman with ruptured silicone gel implants and severe capsular contracture. For help writing your own letter of medical necessity, contact us at info@breastimplantinfo.orgClick here to download.


Breast Implant Removal Office
555 Smiles Way
Healthytown, DC 55555

January 5, 2018

XYZ Claims Department
167 Daisy Lane
Milwaukee, OK 12345

RE: Letter of Medical Necessity for Jane Doe

Group/policy number: 1425-2345-1234
Date(s) of service: January 2, 2018

Dear XYZ Claims Department:

I am writing on behalf of Jane Doe, to document medical necessity and request prior-authorization for explantation of two silicone gel breast implants. Ms. Doe is a 56-year-old female with rupture of her right implant, Baker level III capsular contracture in her left implant, and significant pain in both breasts. She has been in my care since September 21, 2017. Ms. Doe requires an explantation with permanent removal of both implants.

As a result of her pain, Ms. Doe has experienced significant deficits in her daily functioning, including not being able to reach above her head, get dressed, or drive to work. She has previously taken a variety of over-the-counter and prescription pain medications, which have not alleviated her pain. The attached medical records document Ms. Doe’s clinical condition and medical necessity for permanent explantation of both breast implants. There is no equally effective course of treatment available for this patient that is more conservative or less costly.
My patient’s XYZ policy states the following:

“Removal of breast implants that were initially placed for cosmetic purposes is covered when it is considered medically necessary to treat illness or restore the functioning of a body part.”

According to the medical policy of XYZ, Ms. Doe’s breast implant removal should be covered because she has severe capsular contracture that interferes with her daily functioning and has interfered with mammography. Removal of her breast implants and scar tissue surrounding them should relieve her breast pain and eliminate her capsular contracture.

Surgical implant removal is the standard treatment for severe capsular contracture and ruptured silicone-gel breast implants, and this procedure is clinically appropriate for my patient’s condition. Based on the language above, this procedure should be considered medically necessary.

I ask that you take the above information into consideration and offer coverage for Ms. Doe’s medically necessary explant surgery. Should you require additional information, please feel free to contact me at (111) 111-1111 or doctor@iworkhere.org.

Sincerely,

Dr. David Healthcare, Chief of Breast Implant Removal Operations
NPI# 1234567890

Enclosures:
Ms. Doe’s Office Visit Notes from 9/21/2017
MRI Report from 11/10/2017
Ms. Doe’s post-operative report from 1/2/2018

Breast Pain, Redness, or Swelling


You may experience breast pain immediately after your surgery or years after your surgery. It’s important to find out what is causing your breast pain so that you can try to reduce it.

As with any surgery, augmentation patients should expect to feel pain immediately after surgery. However, pain that lasts for months or longer can have many different causes and requires treatment. It can be a sign of an infection, especially if the pain is accompanied by redness, swelling, and tenderness.

Pain can also be caused by capsular contracture, which is when scar tissue that has developed around the implant tightens or hardens. The breast will feel hard and may change shape. The more severe the capsular contracture becomes, the more pain you will experience.

Nerve injury can also cause chronic breast pain or loss of sensation (numbness) of the breast and nipples. Studies have found that between about 13 and 15% of augmentation patients experienced nerve injury or changes in sensation after surgery. Damaged nerves heal slowly and may not ever heal. If the nerve injury is severe enough, additional surgery may be recommended.

Swelling in the breast can be caused by infection, rupture, an inflammation, or Anaplastic Large Cell Lymphoma (ALCL), a cancer of the immune system. If you notice swelling in your breasts, your doctor should test the fluid around your implant for signs of bacteria or signs of cancer.

All articles have been reviewed and approved by Diana Zuckerman, PhD,  and other senior staff.

Autoimmune Symptoms


Breast implant companies were required to complete safety studies before they could sell their implants in the United States. Although the Food and Drug Administration (FDA) approved breast implants, they admitted that “studies would need to be larger and longer” to find out if implants could cause the kinds of diseases many women were reporting.1

Since many women reported problems with autoimmune or connective tissue disorder symptoms such as joint pain, breast implant companies did not study the safety of implants in women who had a family history or personal history of autoimmune disease before getting implants. They intentionally excluded those women because they were concerned that those women might be more likely to have health problems from the implants. Breast implant companies recognize this as a shortcoming of their studies. For example, this is what Mentor says in their label for MemoryGel® implants:2

Safety and effectiveness have not been established in patients with the following:

  • Autoimmune diseases (for example, lupus and scleroderma)…”

Unfortunately, most physicians and most women considering implants are unaware of that warning.

What Is Autoimmune Disease?

Autoimmune disease is a condition where immune cells attack your body. Immune cells usually help our bodies fight off infections and foreign substances. However, these immune cells see silicone as a foreign substance, and that can cause the body to start an immune response.

In some cases, the immune system launches a big enough attack that it starts attacking the body. This could lead to symptoms like joint pain, fatigue, mental confusion, dry eyes, and hair loss. Some women with breast implants report a wide range of symptoms that do not fit into one specific condition. Over time, some women develop a pattern of symptoms that are diagnosed as lupus, scleroderma, or other conditions. Autoimmune diseases can target specific organs, like the brain or liver. They can also involve many tissues, like muscles or blood.3

It is important to know that not all people who get breast implants develop immune problems. Those who develop autoimmune symptoms may have other risk factors, such as allergies or a family history of autoimmune disease.4 In addition, women who already had autoimmune symptoms can get worse symptoms or new symptoms after getting breast implants. Certain genes may also increase the chances of developing autoimmune diseases or symptoms, sometimes as a reaction to silicone or other exposures. In addition, women who already had autoimmune symptoms can get worse symptoms or new symptoms after getting breast implants.

Silicone-related complaints and diagnoses (modified from DeBoer et al, 2011) 

 

Silicone-related complaints

  • Fatigue
  • Muscle aches
  • Aching and painful joints
  • Fever/elevated body temperature
  • Dry eyes, dry mouth (sicca)
  • Poor memory, concentration, or sleep
  • Stroke
  • Numbness, weakness, dizziness, vision changes (Multiple sclerosis)
 

  Silicone-related diagnoses

  • Raynaud’s disease (painful cold, pale, or purplish fingers and toes)
  • Irritable bowel syndrome (diarrhea, constipation)
  • Allergies (food allergies, metal allergies, multiple sensitivities, etc.)
  • Immunodeficiencies (recurrent infections, e.g., pneumonia, sinus infections, diarrhea)
  • Autoimmune diseases (Scleroderma, Lupus, Sjogren’s, etc.)

How “Good” Is the Evidence?

There is conflicting evidence from studies that examined whether breast implants cause autoimmune disease or symptoms. Most studies were funded by implant companies or plastic surgery associations, and they tend to focus on narrowly defined diagnoses, with numerous studies based on hospital records rather than medical records. However, many women with breast implants have reported the same complaints over the last few decades, and many women report that their symptoms greatly improved or completely disappeared after their implants were removed.5

In 2001, FDA scientists reported that women with leaking silicone gel implants were nearly 3 times more likely to have fibromyalgia. Fibromyalgia is a disorder that causes widespread pain in the body as well as fatigue. Little is known about how fibromyalgia develops, but researchers think it is an immune system problem.         

In 2004, scientists from the National Cancer Institute reported that women with breast implants were more likely to have autoimmune symptoms. However, because symptoms were self-reported, the scientists concluded that more research was needed to determine if breast implants caused specific symptoms or diseases.6

In recent years, the discovery that breast implants could cause cancer of the immune system (ALCL) supports the claim that breast implants can have a harmful impact on the immune system.

The Bottom Line

Although well-designed large, long-term studies are lacking, women with implants and autoimmune symptoms have reported for decades that their symptoms improved when their implants were removed. A Dutch study found that among 52 women who had their implants removed, 36 (69%) reported that they felt better, and 9 of the 36 reported that their symptoms were gone. A meta-analysis, which is a type of study that combines the results from several studies, found that on average, 3 out of 4 women who removed their silicone breast implants saw improvement in their symptoms.

However, the prognosis might be better for women with autoimmune symptoms who have their implants removed than for women with a diagnosed autoimmune disease.

Treatments and Alternatives

Here are some symptoms that many women have reported to have developed after getting breast implants.  Some of these symptoms developed almost immediately, but others developed years later.

  • I have achy, sore, or weak muscles.
  • I have achy or stiff joints.
  • I wake up every morning feeling tired or un-refreshed, and no matter how much I sleep, I never feel well-rested.
  • I feel like my head is in a “fog.” I have difficulty concentrating, finding the right word to say, or remembering things.
  • I feel warm or hot even when it’s cold outside.
  • I have dry skin, dry eyes, or hair loss.

If you already have an autoimmune disease, breast implants could make your symptoms worse. If autoimmune disease runs in your family, you may be at increased risk of developing an autoimmune reaction to the silicone implant. If you already have breast implants and have any of the above symptoms, here are some steps to consider:

  • See a rheumatologist. A rheumatologist is a specialist of joint and immune system conditions. The rheumatologist can examine you and order tests if necessary to potentially diagnose any conditions. See a provider you trust and don’t be afraid to get a second opinion. This is your right as a patient!
  • Your doctor may offer you medications to treat your symptoms. For example, he/she may offer you artificial tears to help with dry eyes or suggest medications to decrease inflammation in your body.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

Interference with Breast Cancer Detection


Breast implants make it more difficult to detect breast cancer. If you are considering getting breast implants or already have breast implants, it is important to know how they can make mammography and breast exams less accurate.

Mammography is used to screen for and detect breast cancer. Breast implants make mammography less accurate because they can hide cancer that is growing behind or around the implant. 7

A mammogram is a type of x-ray. Breast tissue will look grey on the mammogram, and cancer will look white. In a mammogram, implants are also white and will look like a bright white orb. If there is cancer in breast tissue that is below or very near the implant on the mammogram, it probably will not be visible, and therefore won’t be detected.

Here is an example of what implants look like on a mammogram:8

Severe capsular contracture can interfere even more with the accuracy of mammography. It can also cause mammography to be unbearably painful. Capsular contracture is when the scar tissue capsule around the implant tightens and hardens. If you have severe capsular contracture, it may not be possible for you to have a mammogram.

If you have breast implants and need to have a mammogram, you should tell the technician that you have breast implants. You can go to a mammography center that has experience doing mammograms on women with breast implants. The technician will need to take extra x-ray pictures and will have to push your implants to the side, which can be painful.

Mammography also can cause breast implants to break (rupture) or leak. If you have silicone gel-filled implants, this rupture may not be noticeable, but it can cause pain or health problems. To prevent extensive leakage, it is important to have regular breast MRIs to check for silicone gel leakage. If the rupture is not detected, silicone gel can leak through the body and cause serious medical problems.

If you have silicone gel breast implants that are leaking, they can cause lumps (silicone granulomas) that are mistaken for breast cancer. It can also be difficult to know when a lump really is breast cancer. If you have any lumps, be sure to have them checked for cancer right away. If they are from leaking silicone, it is important to have your implants removed.

All articles have been reviewed and approved by Diana Zuckerman, PhD, and other senior staff.